MAUDE Adverse Event Report: COOK INC COPE STAINLESS STEEL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that, during a nephrostomy procedure, the distal tip of the cope stainless steel mandril wire guide broke.The physician utilized a device from another supplier to complete the procedure with no adverse events or additional procedures necessitated stating there were no clinical consequences to the patient.The device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record indicated that the lot met all finished goods release criteria.It should be noted there was one other reported complaint for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.The complaint is confirmed on the customer's testimony.We have notified the appropriate personnel and will continue to monitor for similar events.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
Per the customer: at which point in the procedure did the wire guide break? (insertion, manipulation, removal, etc) insertion in the urinary track.Was resistance encountered during introduction or removal of the wire guide? removal.Was the wire being removed through a needle or other instrument? through a needle.Was any kinking of the wire noted? no explanation.Can patient demographics be provided? no information.What was the date of event? (b)(6) 2017.Will photos, operating reports, x-rays, scans, or other imaging be provided? no.Please describe the other products and equipment used during the procedure (endoscope type and model, introducer, wire guide, etc.) a needle 18 gage.Did the patient have a pre-existing condition and/or pre-diagnosis relevant to this event? no explanation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7242599
• Report Number: 1820334-2018-00229
• Device Sequence Number: 11052387
• Product Code: DXQ
• UDI-Device Identifier: 00827002051775
• UDI-Public: (01)00827002051775(17)200901(10)6142306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18-60-COPE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/12/2018; 04/06/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/07/2018; 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1